Unintended Effects of HIV Self-Testing in Female Sex Workers: Evidence from Malawi

1. Does the use of HIV self-testing kits lead to unintended effects? Evidence from female sex workers in Malawi Dr Paul Mee – London School of Hygiene and Tropical Medicine HIVSELF-TESTING AFRICA STAR Initiative

2. Competing interests The authors declare that they have no competing interests.

3. What I will cover today • Background to the study • Summary of research methods and analytical approach • Evidence for regret associated with HIVST use • Evidence for social harms following HIVST use • Conclusions and next steps

4. Background - HIV Self testing in Female Sex Workers • Worldwide Female Sex Workers (FSW) experience high levels of violence 1 • RCTs show HIVST associated with an increased uptake and frequency of testing 2 • HIV Self testing (HIVST) - a safe and acceptable alternative to Facility based testing for FSWs in Zambia, Uganda, Kenya & Zimbabwe 3,4,5,6 • High readiness for HIVST in the General Population in Malawi – preferred to facility based testing 7 • Concerns remain about social harms of HIVST amongst vulnerable groups References 1 Deering K.N. et al . AMJPH (2014 ) 5 Thirumurthy H. et al.  Lancet HIV  (2016) 2 Johnson CC et al JIAS(2017) 6Napierela et al Bull WHO (in press) 3 Chanda, M.M. et al.  PLoS medicine (2017) 7 Choko A.T. et al PLoS medicine. (2015) 4 Ortblad, K. et al. PLoS medicine  (2017)

5. This study - Peer distribution of HIVST to FSW in Malawi • Research led by the team from the Malawi-Liverpool-Wellcome Trust Clinical Research Programme in Blantyre, Malawi (March – December 2017) • Part of a programme of studies into HIVST distribution in Malawi (Kumwenda M.K. et al. JIAS 2019) • Study goals • Investigate appropriate HIVST delivery models among FSW • Monitor for potential social harms • FSWs recruited as peer distributors – 5281 kits distributed , 2001 in Blantyre district • Prizes for most successful distributors • Participants could receive multiple kits over 3 months • Oral Fluid Test HIVST– OraQuick ADVANCE (with WHO pre-qualification approval) • Study protocol (http://hivstar.lshtm.ac.uk/protocols/)

6. Data Collected For each HIVST recipient T= 0 – HIV Self test received Baseline interview Audio Computer Assisted Interviews (ACASI) interview Collected data on socio-demographics, sexual behaviour, testing history , social harms

7. Data Collected For each HIVST recipient T= 0 – HIV Self test received Baseline interview Audio Computer Assisted Interviews (ACASI) interview Collected data on socio-demographics, sexual behaviour, testing history , social harms Three month longitudinal diary Daily reports on sexual behavior & social harms Weekly reports on HIV testing

8. Data Collected For each HIVST recipient T= 0 – HIV Self test received Baseline interview Audio Computer Assisted Interviews (ACASI) interview Collected data on socio-demographics, sexual behaviour, testing history , social harms T= 3 months Endline interview Repeat ACASI interview Changes in sexual behaviour, testing and occurrences of social harms Three month longitudinal diary Daily reports on sexual behavior & social harms Weekly reports on HIV testing

9. Analytical Questions from the endline data • What percentage of participants reported regret about HIVST use or relationship problems associated with HIVST use? • Did this differ by socio-demographic characteristics, test result or test initiator?

10. Characteristics of the study cohort • High rates of Intimate Partner Violence reported at baseline (48.4%) • Data on regrets and relationship problems associated with HIVST use available for 131/265 (49.4 %) • This group slightly older than those not reporting this data

11. Regret and relationship problems amongst those reporting HIVST use at endline Percentage reporting regret about HIVST use was low and decreased over time since test

12. ACASI results III – regret and relationship problems amongst those reporting HIVST use at endline Evidence that relationship problems were greater if someone else initiated the HIVST (mainly peer distributors)

13. ACASI results III – regret and relationship problems amongst those reporting HIVST use at endline No evidence that regret or relationship problems were associated with HIVST result

14. Longitudinal diary Weekly reports of HIV self and facility based testing and coercion to test or disclose test result Daily reports of type of sexual partners , condom use and social harms per partner

15. Longitudinal diary data

16. Longitudinal diary data Analytical Questions i) What evidence is there that social harms are more likely in the week of a test and the following week compared to weeks where no tests occur and following week? ii) Is there evidence that this differs between self tests and facility based tests?

17. Results of GEE analysis Including all individuals with baseline ACASI data (n=222) • Multivariate model using Generalised Estimating Equations (GEE) to account for correlated data within individuals and over time • Some evidence for increase in reports of verbal abuse in week of HIVST and following week 1 Adjusted for total sex encounters per week, age and self identification as sex worker

18. Summary and Conclusions • Peer distribution strategy effective in reaching FSW with HIVST • Percentage of FSW reporting regret about taking HIVST was low and decreased over time • Regret not associated with test result • Further qualitative analysis probing meaning behind “regret” • Relationship problems more likely to be reported if test initiated by another person (mainly peer distributor) • Therefore important to consider alternative models to peer distributors for HIVST distribution among FSW • Some evidence in this small study population for increase in reports of verbal abuse following HIVST use for peer distribution model • Based on this and other studies – It is important to consider HIVST as an alternative where safe, acceptable and effective for reaching PLHIV in key at risk populations

19. Acknowledgements • Study participants • STAR project funders - Unitaid • Co-authors - Melissa Neuman1, Moses Kumwenda2, Mwiza Sambo2, Wezzie Lora 2 ,Pitchaya Indravudh1,2, Karin Hatzold3, Cheryl Johnson4, Liz Corbett1,2, Nicola Desmond2 1London School of Hygiene and Tropical Medicine, UK 2 Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi 3Population Services International, Johannesburg, South Africa 4 Department of HIV/AIDS, WHO Geneva, Switzerland paul.mee@lshtm.ac.uk